BACKGROUND: Clinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. AIMS: To identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics. METHOD: A survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register. RESULTS: Extrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent. CONCLUSIONS: The way in which safety and tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.
BACKGROUND: Clinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice. AIMS: To identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics. METHOD: A survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register. RESULTS: Extrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent. CONCLUSIONS: The way in which safety and tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.
Authors: Brooke Short; Vanessa Dong; Verònica Gálvez; Vedran Vulovic; Donel Martin; Adam J Bayes; Carlos A Zarate; James W Murrough; Declan M McLoughlin; Patricio Riva-Posse; Robert Schoevers; Renerio Fraguas; Paul Glue; Johnson Fam; Rupert McShane; Colleen K Loo Journal: J Affect Disord Date: 2020-01-25 Impact factor: 4.839
Authors: Stefan Leucht; Johannes Hamann; Spyridon Siafis; Nicola Bursch; Katharina Müller; Lisa Schmid; Florian Schuster; Jakob Waibel; Tri Huynh; Florian Matthes; Alessandro Rodolico; Peter Brieger; Markus Bühner; Stephan Heres Journal: BMC Psychiatry Date: 2022-06-17 Impact factor: 4.144
Authors: Luis Molina; Byron Recinos; Bezner Paz; Mauricio Rovelo; Fanny Elizabeth Elias Rodriguez; José Calderón; Arturo Arellano; Santiago Pomata; María Verónica Rey; Santiago Perez-Lloret Journal: Clin Drug Investig Date: 2016-06 Impact factor: 2.859
Authors: T Wykes; J Evans; C Paton; T R E Barnes; D Taylor; R Bentall; B Dalton; T Ruffell; D Rose; S Vitoratou Journal: Psychol Med Date: 2017-04-19 Impact factor: 7.723
Authors: Thomas R E Barnes; Verity Leeson; Carol Paton; Louise Marston; David P Osborn; Raj Kumar; Patrick Keown; Rameez Zafar; Khalid Iqbal; Vineet Singh; Pavel Fridrich; Zachary Fitzgerald; Hemant Bagalkote; Peter M Haddad; Mariwan Husni; Tim Amos Journal: Ther Adv Psychopharmacol Date: 2018-03-08